Jim Moran

	As the importance of translational research continues to grow, with focus placed on comparative effectiveness and outcomes-based research through translational science awards

 and the American Recovery and Investment Act,

 research institutions are exploring other options to remain competitive players in the academic clinical research arena. Among the options, many academic institutions are partnering with the federal government and industry to reinvest in bench research and clinical trials.

 The results of this investment have been an increase in the number of clinical research trials being conducted simultaneously, as well as a rise in the number of investigational products (including devices and biologics) being tested. This combined effort has placed a compliance burden at academic research institutes (AMIs) or academic health centers.

 To mitigate compliance issues and gain operational efficiencies, many academic centers are implementing clinical research software solutions to assist in managing the flow of information in their growing clinical research portfolios. 

Exploring the benefits of clinical trial management system

	As mentioned above, academic research institutions are assessing options to better control the flow of information and mitigate compliance issues in non-clinical and clinical research trials. One option for academic institutions is to implement a fully integrated clinical trial management system (CTMS).CTMSs are designed to be customizable enterprise-wide solution to manage, collect, and analyze data collected during the entire preclinical and clinical trial process. The benefits of mapping and developing an enterprise wide solution include:

		Optimizing institutional review board (IRB) functionality

		Realizing real-time data available to both investigators and leadership

		Decreasing bottlenecks in knowledge transfer between various entities involved in research

		Reducing human errors in reporting that often cause compliance issues

		Tracking milestones for grants, awards, fellowships, etc.

		Streamlining the financial structure-billing and invoicing

	By implementing a CTMS, AMIs are moving away from antiquated non-integrated manual processes and turning to technical solutions to manage the flow of information associated with conducting clinical trials.

	A successful CTMS can provide a well-organized flow of knowledge throughout the institution and assist senior management in obtaining real-time data to better analyze the current state of their clinical research enterprise. Armed with milestone-based, real-time data, senior management, such as business unit directors and department chairpersons, are better equipped to make strategic decisions to improve overall operational effectiveness, compliance, governance, and infrastructure (see Figure 1). The following list highlights some of the operational, infrastructure, compliance, and governance issues that can be improved through the implementation of a CTMS:


	Figure 1. CTMS impact in three key areas.

 With a better understanding of resources, management will be capable of reallocating staffing assignments to offset excess or inadequate roles.

 Improved communication will improve patient satisfaction and monitoring of clinical trials.

 CTMSs have integrated checking components to limit errors in reporting.

Improved knowledge flow in various divisions (finance, marketing, administration, training, and recruitment) will help to achieve real-time results and data.

More accurate and efficient reporting tools will be useful internally and externally for current and future project assessments.

Choosing a CTMS that serves your institutional needs

	There are three general types of CTMS: web-based, cloud-based, and on-site hosted-based software.

 Each type has distinct advantages and may have disadvantages depending on the IT infrastructure at the respective academic medical center. In order to understand your institutional needs, we suggest starting with defining the purpose or mission of your CTMS. Once the mission(s) or purpose is defined, then the disparate systems or system gaps can be assessed and mapped. During the mapping exercise, consider exploring the following missions and/or purposes to build use cases of a well-balanced, operationally efficient, and compliant CTMS:

		Improvements in clinical, administration, and financial management of research

		Fostering and improving collaborations among investigators

		Greater understanding of the progress and revenue impact of clinical trials

		Increasing subject recruitment and safety through the institution

		Reducing errors and increasing facility compliance

		Operating efficiently and saving research time					 	

	Prior to purchasing or implementing a CTMS, it is necessary to assess the institution's operational, compliance, and governance needs and priorities, as well as outline current software systems (see Table 1). Establishing priorities and identifying current systems can be done in mapping sessions. In these sessions, a cross-functional team of principal investigators, study coordinators, and senior leadership (such as the chief information officer, chief financial officer, human resources representatives, and chief compliance officer) are allowed to identify future system requirements, outline current software system gaps, and weigh operational, governance, and compliance priorities. For instance, leadership may insist upon certain compliance management reporting capabilities, while investigators may require that the system track pre-award study start-up milestones, financial reconciliation, and integrate with electronic health records (EHR). Next, a gap analysis of the research institute's current software system's capabilities and the requirements identified in the mapping sessions versus CTMS-specific capabilities is completed. The will help to identify the best CTMS fit for the institution.


	Table 1. Important considerations when choosing a CTMS.

	After this step, the vendor selection process can begin. Based on the mapping, most institutions will not be able to pick a system off the shelf that is fully operational for their clinical research needs. This makes choosing a system somewhat more complicated than implementing many other types of institutional systems, such as financial, electronic health management, and other point of service systems. CTMSs have the potential to solve many of the compliance, governance, operational, and managerial issues at academic medical centers with analytics and reports. So which system do you choose? Unfortunately, for these institutions, currently there are no perfect, one-size-fits-all CTMSs available in the market. Even though there is no perfect system, consider reviewing of some common elements among most of the best systems:

		Financial reporting tools (coverage analysis, residual and overage reporting)

		Clinical trial management tools (including applicable clinical trial milestones and reporting dashboards)

		Integrates easily with electronic medical records (EMRs), institutional review board (IRB) system(s), etc.

	As the market demand for computerized CTMSs increases, so does the number of systems solutions. Thus, we may be getting closer to a system that effectively manages all aspects of the clinical trial process at academic centers. Until then, any CTMS implementation will require a certain amount of mapping, customization, and implementation support, and may not serve all analytical and reporting needs.

	CTMSs can come with a hefty price tag. In our experience, the purchase and implementation of a CTMS often means a commitment of two or more years and costs can run into the millions of dollars. It is essential to take all implementation costs into consideration before choosing a CTMS. Many systems offer somewhat low "off the shelf" prices, but these prices don't reflect the true cost. It is necessary to consider not only the cost of the system itself, but the cost of customization, migration of data from legacy systems (EDC and data warehouses), integration with other disparate research (IRB, Lawson, EHR) systems, training, and roll-out timeline when choosing a CTMS. One other cost consideration is to engage a third party to assist during the system selection and implementation phases to provide program management for such a large investment.

	In our experience with the implementation of CTMSs, the following are key aspects of the process:

The most important aspect of implementing a CTMS is having a committee that is capable of making well-informed decisions for the institution.

 Know the current and future issues of the institution that hope to be resolved with the CTMS.

Understand that implementing a CTMS will come with new responsibilities. The institution should be prepared to have individuals fill these new roles. Without this preparation, the CTMS is doomed from the beginning. New hires might not be necessary, but rather a shift in responsibilities. Create a culture of transparency to eliminate conflict and inconsistencies in the future.

 Design an ongoing tailored training program to meet the short- and long-term needs of staff. Implement training and train staff on the new technology.

 Consider bringing in an unbiased firm to help people in the institution understand the true benefits of change. Theå firm can also provide management with options for implementation, interface, and utilization.

	In today's clinical research environment, it is no longer enough to have a disparate stand-alone system that tracks clinical trials. In reality, a successful CTMS solution will require integration with other systems such as EHR, IRB, and financials linking all preclinical and clinical research processes together. This integration creates a powerful database for clinical trials management, enabling AMIs access to real-time data and allowing them to maintain and manage various stages of clinical trials through CTMS data analytics.

	Along with strategic, governance, and operational improvements, a successful CTMS can improve patient satisfaction, increase return on investments, enhance communication between departments, increase the volume of completed trials, and generate an overall more efficient clinical research portfolio.

is Executive Director, all in the Advisory Services practice of Ernst & Young.

The views expressed are those of the authors and do not necessarily reflect the views of Ernst & Young LLP.

	1. CTSA Home Page, "Clinical & Translational Science Awards Portal." 

	2. "NIH and the American Recovery & Reinvestment Act (ARRA)." 

	3. "Sparking Economic Growth." The Science Coalition. 

http://www.sciencecoalition.org/reports/Sparking%20Economic%20Growth%20Full%20Report%20FINAL%204-5-10.pdf

	4. "Academic-Industry Partnerships for Biopharmaceutical Research." 

http://csdd.tufts.edu/files/uploads/tuftscsdd_academic-industry.pdf

	5. "Investing in Clinical Trial Compliance." Association of Academic Health Centers. 

http://www.aahcdc.org/policy/reddot/AAHC_Investing_in_Clinical_Trial_Compliance.pdf

	6. "EDC Focus: "Making The Right Investment In CTMS/EDC." 

http://www.contractpharma.com/issues/2009-11/view_features/edc-focus-making-the-right-investment-in-ctms-edc/

	7. "Clinical Trial Management Systems (CTMS) Market: Global Trends, Opportunities, Challenge and Forecasts (2011 - 2016)." 

http://www.prnewswire.com/news-releases/clinical-trial-management-systems-ctms-market-global-trends-opportunities-challenge-and-forecasts-2011---2016-138385234.html

Articles

As the importance of translational research continues to grow, research institutions are exploring other options to remain competitive players in the academic clinical research arena.

Steps for a Successful Clinical Trial Management System

	The excessive cost of clinical trials mixed with the inefficiency of clinical trial management is a widespread problem among research institutions. As the importance of translational research continues to grow, with focus placed on comparative effectiveness and outcomes-based research through the new health care reform acts, research institutions need to “step it up” if they want to remain competitive players in the academic clinical research arena. Most academic medical centers (AMCs) are plagued with many of the same issues, including:

		Decentralized departments leading to inconsistent administrative processes

		Poor institutional review board (IRB) functionality

		Lack of real-time data available to both investigators and leadership and the inability to successfully track and schedule patients

		Bottlenecks in knowledge transfer between various entities involved in research

		Human errors in reporting that often cause compliance issues

		Missing milestones for grants, awards, fellowships, etc.

		Inadequate financial structure - billing and invoicing issues leading to disparities in payment and potential compliance issues


	Research institutions can look to clinical trial management systems (CTMS) to alleviate the burdens associated with clinical research management. By implementing CTMS, research institutions are moving away from antiquated non-integrated manual processes and turning to technical solutions to mitigate the above-listed problems associated with conducting clinical trials.

	A successful CTMS can provide a well-organized flow of knowledge throughout the institution and help senior management obtain real-time data to better analyze the current state of the clinical research landscape. Armed with milestone-based, real-time data, senior management is better equipped to make strategic decisions to improve overall operational effectiveness, compliance, governance and infrastructure (see Figure 1). The list below highlights some of the operational, infrastructure, compliance and governance issues that can be improved by implementing a CTMS:

: With a better understanding of resources, management will be capable of reallocating staffing assignments to offset excess or inadequate roles.

: Improved communication will improve patient satisfaction and monitoring of clinical trials.

: CTMS have integrated checking components to limit errors in reporting.

: Improved knowledge flow in various divisions (finance, marketing, administration, training and recruitment) will help to achieve real-time results and data.

: More accurate and efficient reporting tools will be useful internally and externally for current and future project assessments.

	There are three general types of CTMS: web-based, cloud-based and on-site hosted-based software. Each type has advantages and disadvantages depending on the IT infrastructure at the respective academic medical institution. In the next section, we will further discuss how to map the system and conduct a gap analysis of your research institute needs. During the mapping exercise, the following uses should be explored to enable the implementation of a well-balanced, operationally efficient and financially effective CTMS:

		Improvements in clinical, administration and financial management of research

		Operating efficiently and saving research time

	Unfortunately, although CTMS have the potential to solve many of the compliance, governance, operational and managerial issues at research institutions, there is currently no perfect, one-size-fits-all CTMS available in the market, and implementation is often challenging. Even though there is no perfect system, there are common elements among most of the best systems:

	As the market demand for computerized CTMS increases, so does the number of systems solutions. Thus, we may be getting closer to a system that effectively manages all aspects of the clinical trial process at AMCs. Until then, any CTMS implementation will require a certain amount of mapping, customization and implementation support. Unfortunately, these elements are as costly as they are necessary.

Procuring the right CTMS for your research institute

	Prior to purchasing or implementing a CTMS, it is necessary to assess the institution’s operational, compliance and governance needs and priorities, as well as outline current software systems. Establishing priorities and identifying current systems can be done in mapping sessions. In a mapping session, a cross-functional team of principal investigators, study coordinators and senior leadership (such as the chief information officer, chief financial officer, human resources representatives and chief compliance officer) are allowed to identify future system requirements, outline current software system gaps and weight operational, governance and compliance priorities. For instance, leadership may require certain compliance management reporting capabilities, while investigators may require that the system track pre-award study start-up milestones.

	Figure 4 illustrates a typical mapping exercise. Next, a gap analysis of the research institute’s current software system’s capabilities and the requirements identified in the mapping sessions versus CTMS-specific capabilities is completed. The analysis will help to identify the best CTMS fit for the institution.

	After mapping system requirements and establishment of priorities are completed, the vendor selection process can begin. Based on the mapping, most institutions will not be able to pick a system off the shelf that is fully operational for their clinical research needs. This makes choosing a system somewhat more complicated than implementing other types of institutional systems such as financial, electronic health management, and other point of service systems.


	CTMS are expensive to implement. It is essential to take all implementation costs into consideration before choosing a CTMS. Many systems offer somewhat low “off the shelf” prices, but these prices don’t reflect the true cost. It is necessary to consider not only the cost of the system itself, but the cost of customization, migration of data from legacy systems, integration with other systems, training and roll out timeline when choosing a CTMS. Third-party assistance during the system selection phase is often beneficial for institutions wanting a comprehensive approach to making such a large investment.

	Purchase and implementation of a CTMS often means a commitment of two or more years and can cost upwards of $3 million. Institutional commitment, as well as any outside consulting services, should be dedicated to implementation. Furthermore, successful implementation must be supported by senior leadership and managed by a project management team. In our experience with the implementation of CTMS, the following are key aspects of the process:

: The most important aspect of implementing a CTMS is having a committee that is capable of making well-informed decisions for the institution.

: Know the current and future issues of the institution that hope to be resolved with the CTMS.

: Understand that implementing a CTMS will come with new responsibilities. The institution should be prepared to have individuals fill these new roles. Without this preparation, the CTMS is doomed from the beginning. New hires might not be necessary, but rather a shift in responsibilities. Create a culture of transparency to eliminate conflict and inconsistencies in the future.

: Design an ongoing tailored training program to meet the short and long-term needs of staff.  Implement training and train staff on the new technology.

: Consider bringing in an unbiased firm to help people in the institution understand the benefits of change. An external firm can also provide management with options for implementation, interface and utilization.


	As mentioned above, although it is crucial, it is no longer enough to have a stand-alone system that tracks studies or helps produce management reports on clinical trials. In reality, a truly successful technological solution to clinical trial management will require integration with other systems such as EMR, IRB and financials. This is currently an area in which most CTMS have not succeeded, and one that, again, will become increasingly important through health care reform and as the bridging of payers and providers to determine quality standards becomes more commonplace. Institutions need to be able to link CTMS with the other institutional systems. The integration will help create a powerful database for management, and institutions will have real-time access to data allowing them to maintain and manage various stages of clinical trials. Researchers will have the ability to keep up-to-date contact information for participants and track deadlines and milestones.

	A successful CTMS connects all aspects of clinical trial management and allow administration to focus on balancing the financial reports with accurate and real-time recruitment data. Along with strategic, governance and operational improvements, a successful CTMS can improve patient satisfaction, increase ROIs, enhance communication between departments, increase the volume of completed trials, and generate an overall more efficient clinical research portfolio.

	The views expressed herein are those of the authors and do not necessarily reflect the views of Ernst & Young LLP.


	Erika Stevens is a senior manager in the Advisory Services practice of EY. Erika has more than 18 years of academic medical center, hospital and clinical research experience, including more than 15 years in clinical research management serving in roles such as the director of the Clinical Trials Office, regulatory training manager, director of clinical research and director of research operations. Erika is the chair of the editorial advisory board for The Monitor, the peer-reviewed journal publication for the Association of Clinical Research Professionals, and she serves on the Global Conference Planning Committee.

	Christina Eberhart is a manager in the Advisory Services practice of EY. She has more than 13 years of clinical research experience, contributing in such roles as director of clinical operations, director of quality assurance, clinical research associate, manager of quality assurance and the principle of an investigator trial network. Christina is a national speaker on several clinical research topics for the Association of Clinical Research Professionals, Drug Information Association and MAGI.

	Jim Moran is an Executive Director in the Advisory Services practice of EY with more than 18 years of experience working with universities, hospitals, academic medical centers and cancer centers as a research operating officer, chief compliance officer and consultant. Jim’s deep industry background includes developing multi-million dollar growth platforms for translational research and helping health care organizations improve clinical research operations, improve quality of care, manage regulatory risk and identifying innovative opportunities for leading research organizations to capitalize on their clinical research strengths. Jim is a frequent presenter at national and regional conferences on clinical research operations and regulatory compliance topics.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-109.html

http://grants.nih.gov/grants/policy/coi/coi_faqs.htm

http://journal.ahima.org/2010/04/29/californian-sentenced-to-prison-for-hipaa-violation/

	 “Columbia discovers fiscal benefits with clinical trial oversight,” HealthImaging.com, 14 April 2010, 
	

http://www.healthimaging.com/index.php?option=com_articles&view=article&id=21620&division=hiit

The excessive cost of clinical trials mixed with the inefficiency of clinical trial management is a widespread problem among research institutions.

Academic Medical Centers Can Tackle CTMS Successfully

There are several reasons why institutions should place greater emphasis on patient recruitment. First and foremost, hospitals, academic medical centers and other medical institutions involved in clinical research strive to advance science and improve the quality of health care. Without the appropriate participant population in a study, the results will not reach the public. 
  
  Institutions also must recognize that advanced recruitment capabilities can lead to more revenue. In a sponsor-initiated research study, institutions receive dollars for every patient enrolled. The formula is simple: more patients equals more dollars. The revenue covers the costs of the study but can also contribute to funding additional research infrastructure and growing the research enterprise.
  
Sponsors prefer to partner with institutions that can deliver. Institutions with a track record of meeting and/or exceeding enrollment targets are more likely to attract sponsored studies. This leads to additional fiscal return on investment and increased participation in breakthrough research studies. It’s a beneficial cycle that all leads back to recruitment.

However, recruitment does not have to be a challenge. Developing a recruitment plan with the following in mind, can significantly improve the odds of success.  
  
  


  
  The feasibility process offers study teams an opportunity to critically examine their ability to carry out a protocol prior to committing to a study. Accurately assessing whether a team can meet the objectives of the protocol and deliver research results is key to success. Instead of asking investigators whether they expect to meet enrollment targets, institutions should implement processes to perform a true analysis of patient population. This can be done through using an electronic medical record (EMR) system and ICD-9/ICD-10 codes as a search mechanism for identifying patients who might fit the criteria, or by utilizing some sort of database or other technology. 
  
  Penn Medicine, part of the University of Pennsylvania Health System, is using its EMR to aid in patient recruitment for clinical research. At Penn Medicine, participant criteria can be “embedded as an alert in the ambulatory EMR,” and “if a patient matches the criteria, his or her doctor gets a message on the patient’s EMR screen.” (2)  
  
  

Using technology for clinical trials recruitment


  
  Like Penn Medicine, many institutions are using database technology for recruiting purposes. Databases allow institutions to determine high-level eligibility criteria, submit requests, run queries and generate reports that assist in recruitment decision-making. Some institutions promote using a clinical detection intelligence system (CDIS) that interfaces with electronic medical records and enables eligibility criteria logic to be programmed into the EMR system. This allows institutions to receive alerts and study teams to be notified when patients meet eligibility criteria. (3)
  
  Other institutions opt for a separate recruitment database. Washington University in St. Louis has long been at the forefront of this effort, building a comprehensive participant registry database that houses information about patients and healthy volunteers who would consider participating in a research trial.  This proactive measure allows the school to collect information on potential participants and salient characteristics such as disease type and medications. The database’s search capabilities make it simple to identify whether a particular study has enough qualified participants. (4)  
  
  Social media also has a role to play in recruitment. Institutions can use Facebook, Twitter and others to not only spread the word about research, but also to build a community of individuals who might be interested in becoming a participant. Debi Brooks, Co-Founder of the Michael J. Fox Foundation, which funds research aimed at finding a cure for Parkinson’s disease, says, “One of the biggest challenges is the slowness of recruitment to clinical trials.” 
  
  To overcome this challenge, Brooks developed a system she calls “a Match.com for Parkinson’s patients.” (5) Patients provide information that recruiters can sift through to find potential fits. All information is de-identified. ResearchMatch, a collaboration of more than 60 research institutions affiliated with the Clinical and Translational Science Awards (CTSAs), is another such system. (6) The benefits are clear: as of January 2012, “Over 119,900 ResearchMatch study invitations have been sent to our volunteers and over 2,400 volunteers have been enrolled in studies.” (7)
  
  

Strengthening roles and responsibilities for the recruitment process


  
  Many large academic medical centers and health system hospitals, primarily those who are CTSA recipients, advocate developing a recruitment core. The core helps study teams identify participants for trials and also manages any recruitment database or related technology. At Washington University in St. Louis, studies were reaching, on average, only 60% of the enrollment targets. The development of the Recruitment Enhancement Core helped studies reach 125% enrollment during the pilot period. (8) 
  
  Regardless of whether institutions opt for this route, they should define roles and responsibilities better throughout the process. Who is responsible for identifying target participants? Who is responsible for initial screening? Does everyone with a role have the appropriate training necessary to carry out their responsibilities? These are the types of questions institutions must ask themselves in designing an efficient recruitment process. Without a process, recruitment becomes everyone’s responsibility and therefore no one’s responsibility.
  
  


It can be argued that recruitment is the most important key to a successful clinical research study, and it can no longer be placed on the back burner of the research process. Critical analysis at the onset of every study and proactive measures to attract and recruit participants are essential. Without human subjects to test new scientific discoveries, those discoveries will never impact the quality of care available to the public.

Jim Moran and Erika Stevens are part of Ernst & Young’s Clinical Research Team within the Health Care Advisory Practice.
  The views expressed herein are those of the authors and do not necessarily reflect the views of Ernst & Young LLP.

Presentation: “Research Participant Registry,” Charles Rathmann, Washington University School of Medicine, ACRP NY Metropolitan Chapter Education Event, May 2011; Reference:  K. Getz, CIS, Tufts CSDD and R. Krall, KMR 2006 Data (15 Large Pharma Companies). 

“How Penn Medicine Mines E-Records For Clinical Trial Prospects,” InformationWeek.com, 

www.informationweek.com/news/global-cio/interviews/231600960

Debra L. Henninger, Geisenger Health System, ACRP Metro NY Fall Symposium, September 2011  

Washington University of St. Louis, Institute for Clinical and Translational Sciences, Recruitment Enhancement Core, 

“Michael J. Fox Foundation Cofounder Creates The Match.com Of Clinical Trials,” Forbes.com, 

www.forbes.com/sites/jennagoudreau/2012/02/24/michael-j-fox-foundation-parkinsons-research-creates-match-com-clinical-trials-debi-brooks

https://www.researchmatch.org/?rm=NCATS  

https://www.researchmatch.org/about/index_news.php

Presentation: "The Recruitment Enhancement Core — Innovative Recruitment Strategies for Washington University School of Medicine,” Charles Rathmann, Washington University School of Medicine, Third Annual Clinical Research Management Workshop, 22 June 2010.  

Jim Moran

Articles

Steps for a Successful Clinical Trial Management System

Academic Medical Centers Can Tackle CTMS Successfully

Why Institutions Should Place More Emphasis On Clinical Research Patient Recruitment